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Thalidomide in Treating Patients With Relapsed or Progressive Systemic Mastocytosis

Phase II Study of Thalidomide in Mastocytosis

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00769587
Enrollment
Unknown
Registered
2008-10-09
Start date
2007-06-30
Completion date
2012-10-31
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Neoplastic Condition, Precancerous Condition

Keywords

aggressive systemic mastocytosis, smoldering systemic mastocytosis

Brief summary

RATIONALE: Thalidomide may stop the growth of systemic mastocytosis by blocking blood flow to the disease. PURPOSE: This phase II trial is studying how well thalidomide works in treating patients with relapsed or progressive systemic mastocytosis.

Detailed description

OBJECTIVES: Primary * Determine the objective response rate at 6 months in patients with systemic mastocytosis treated with thalidomide. Secondary * Determine the tolerability of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive oral thalidomide once daily for 6 months in the absence of disease progression.

Interventions

DRUGthalidomide

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Diagnosis of systemic mastocytosis * Aggressive or borderline (smoldering) disease (in first line or more) * Relapsed or progressive disease * Measurable or evaluable disease * Presence of c-Kit D816V mutation in the skin, spine, or infiltrated organs * No nonsymptomatic mastocytosis PATIENT CHARACTERISTICS: * Life expectancy \> 3 months * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception for 1 month prior to, during, and until first menstrual cycle after completion of study treatment * Bilirubin \< 2 times normal (unrelated to disease) * Liver enzymes \< 2 times normal (unrelated to disease) * Creatinine ≤ 300 mmol/L * No central or peripheral neuropathy leading to psychiatric concerns * No HIV positivity * No active infection or other serious underlying illness that would preclude treatment * No history of thromboembolism or deep vein thrombosis * No geographical, social, or psychological reasons preventing medical monitoring PRIOR CONCURRENT THERAPY: * More than 4 weeks since prior antitumor therapy (e.g., chemotherapy, radiotherapy) * No other concurrent treatment specific for this disease * No concurrent participation in another experimental drug trial

Design outcomes

Primary

MeasureTime frame
Objective reduction of the infiltration rate at 6 months6 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026